Frequently Asked Questions
Does my Taiwan Agent need to appear on the labeling?
Yes, as the Taiwan Agent’s information must be included on the Chinese label, along with the registration number. The distributor will also usually add their information with a sticker. the Taiwan Agent’s name and address must be listed on the label and packaging (in Chinese language).
Is ISO 13485 required?
For non-US manufacturers, ISO 13485:2003 is a required element of the QSD Letter Application for Class I (partial list), Class II and III devices, as well as high risk and new devices. US companies can alternatively submit their Establishment Inspection Report issued by the FDA, as long as the inspection was conducted within the past three years.
Can registration certificates be transferred?
Yes, the Taiwan Agent responsibility can be transferred as long as the original Agent cooperates, as the request must be submitted by both agents. Additionally, the registration letter can be transferred simultaneously with the QSD Approval Letter.